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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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ONO-7913 Phase I Study (ONO-7913)

  • Clinicaltrials.gov identifier

    NCT04403308

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 27, 2020

  • Last update posted

    May 10, 2021

Study Description

Brief summary:

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

  • Condition or Disease:Solid Tumor
  • Intervention/Treatment: Biological: ONO-7913
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 7 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: May 2023
  • Estimated Study Completion Date: May 2023

Arms and interventions

Arm Intervention/treatment
Experimental: ONO-7913 as a Single Agent
Biological: ONO-7913
ONO-7913 will be administered by intravenous continuous infusion during the designated time.

Outcome Measures

  • Primary Outcome Measures: 1. Dose-limiting toxicities [ Time Frame: 28 days ]
    Number of participants with a DLT
  • 2. Adverse events [ Time Frame: Up to 24 months ]
    Assessed by the NCI CTCAE v5.0 criteria
  • Secondary Outcome Measures: 1. Concentration vs time of ONO-7913 as single dose [ Time Frame: Up to 24 months ]
    PK profile

Eligibility Criteria

  • Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: 1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status of 0-1 3. Patients with life expectancy of at least 3 months Exclusion Criteria: 1. Patients with multiple cancers 2. Patients with history of serious allergy

Contacts and Locations

Contacts

Locations

Japan, Tokyo
Local Institution
Chuo-ku

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

Study Chair: Kazuhiro Nakabayashi Ono Pharmaceutical Co. Ltd

More Information

  • Responsible Party: Ono Pharmaceutical Co. Ltd
  • ClinicalTrials.gov Identifier: NCT04403308 History of Changes
  • Other Study ID Numbers: ONO-7913-01
  • First Posted: May 27, 2020 Key Record Dates
  • Last Update Posted: May 10, 2021
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • URL: https://www.ono.co.jp/eng/rd/policy.html
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No